Molecule
Levacetylleucine is a prescription medicine indicated for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15 kg, among other approved uses. It is available as oral suspension. MedsAcross supplies Levacetylleucine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
AQNEURSA is indicated for the treatment of: • neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15 kg. • ataxia in adults and pediatric patients with ataxia-telangiectasia (A-T) weighing ≥15 kg.
Source: US FDA prescribing information
The distinct molecular target for levacetylleucine in the treatment of NPC or A-T is unknown.
Source: US FDA prescribing information
• For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment. • Recommended dosage. Patient Body Weight Morning Dose Afternoon Dose Evening Dose 15 to <25 kg 1 g No Dose 1 g 25 to <35 kg 1 g 1 g 1 g 35 kg or more 2 g 1 g 1 g • See the full prescribing information for administration instructions.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 7 days after the last dose if AQNEURSA is discontinued.
Source: US FDA prescribing information
In NPC, the most common adverse reactions (incidence ≥5% and greater than placebo) are abdominal pain, dysphagia, upper respiratory tract infections, and vomiting. In A-T, the most common adverse reactions (incidence ≥5% and greater than placebo) are fall, skin laceration, and urinary tract infection.
Source: US FDA prescribing information
• N-acetyl-DL-leucine or N-acetyl-D-leucine: Avoid concomitant use with AQNEURSA. • P-glycoprotein (P-gp) Transporter Substrates: Monitor for adverse reactions if used with AQNEURSA.
Source: US FDA prescribing information
Store AQNEURSA at room temperature between 20°C to 25°C (68°F to 77°F), excursion permitted between 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Levacetylleucine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Aqneursa 1000 mg oral suspensionOral | IntraBio | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 24 September 2024 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 1 presentations of Levacetylleucine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Levacetylleucine, including Aqneursa.
Yes. The US FDA first approved Levacetylleucine on 24 September 2024, according to Drugs@FDA.
No listed presentation of Levacetylleucine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.